Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
Trop Med Int Health. 2010 Feb;15(2):251-8. doi: 10.1111/j.1365-3156.2009.02445.x. Epub 2009 Dec 9.
To assess the outcome of patients who experienced treatment failure with antiretrovirals in sub-Saharan Africa.
Analysis of 11 antiretroviral therapy (ART) programmes in sub-Saharan Africa. World Health Organization (WHO) criteria were used to define treatment failure. All ART-naive patients aged >or=16 who started with a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen and had at least 6 months of follow-up were eligible. For each patient who switched to a second-line regimen, 10 matched patients who remained on a non-failing first-line regimen were selected. Time was measured from the time of switching, from the corresponding time in matched patients, or from the time of treatment failure in patients who remained on a failing regimen. Mortality was analysed using Kaplan-Meier curves and random-effects Cox models.
Of 16 591 adult patients starting ART, 382 patients (2.3%) switched to a second-line regimen. Another 323 patients (1.9%) did not switch despite developing immunological or virological failure. Cumulative mortality at 1 year was 4.2% (95% CI 2.2-7.8%) in patients who switched to a second-line regimen and 11.7% (7.3%-18.5%) in patients who remained on a failing first-line regimen, compared to 2.2% (1.6-3.0%) in patients on a non-failing first-line regimen (P < 0.0001). Differences in mortality were not explained by nadir CD4 cell count, age or differential loss to follow up.
Many patients who meet criteria for treatment failure do not switch to a second-line regimen and die. There is an urgent need to clarify the reasons why in sub-Saharan Africa many patients remain on failing first-line ART.
评估在撒哈拉以南非洲地区经历抗逆转录病毒治疗失败的患者的结局。
对撒哈拉以南非洲地区的 11 项抗逆转录病毒治疗(ART)项目进行分析。采用世界卫生组织(WHO)标准定义治疗失败。所有起始接受非核苷类逆转录酶抑制剂(NNRTI)为基础方案且至少有 6 个月随访的年龄≥16 岁的初治患者均符合入组条件。每例切换到二线方案的患者,均匹配 10 例继续维持一线方案但未失败的患者。时间从切换的时间、匹配患者的相应时间或维持失败方案的患者治疗失败的时间开始测量。使用 Kaplan-Meier 曲线和随机效应 Cox 模型分析死亡率。
在 16591 例开始接受 ART 的成年患者中,有 382 例(2.3%)切换到二线方案。另有 323 例(1.9%)尽管发生免疫或病毒学失败,但未切换方案。切换到二线方案的患者 1 年死亡率为 4.2%(95%CI 2.2-7.8%),继续维持失败一线方案的患者为 11.7%(7.3%-18.5%),而继续维持非失败一线方案的患者为 2.2%(1.6-3.0%)(P<0.0001)。死亡率的差异不能用 CD4 细胞最低点计数、年龄或随访差异来解释。
许多符合治疗失败标准的患者并未切换到二线方案,并且死亡。迫切需要澄清撒哈拉以南非洲地区许多患者仍继续维持失败一线 ART 的原因。